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The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.

Lian F, Tian J, Chen X, Li Z, Piao C, Guo J, Ma L, Zhao L, Xia C, Wang CZ, Yuan CS, Tong X - PLoS ONE (2015)

Bottom Line: There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01).No serious adverse events were reported.Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone.

View Article: PubMed Central - PubMed

Affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

ABSTRACT

Background: Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone.

Methods: A total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2 h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA-β) were also evaluated.

Results: At week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69-1.14 for the Jinlida group vs. 0.34-0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2 h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported.

Conclusion: Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy.

Trial registration: Chinese Clinical Trial Register ChiCTR-TRC-13003159.

No MeSH data available.


Related in: MedlinePlus

Changes in HbA1c, FPG and 2 h PG in the Jinlida group and placebo group.(A) Left: The mean HbAlc decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (B) Left: The mean FPG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (C) Left: The mean 2 h PG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. Data presented as mean ± S.E. *p < 0.05. **p < 0.01.
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pone.0130550.g003: Changes in HbA1c, FPG and 2 h PG in the Jinlida group and placebo group.(A) Left: The mean HbAlc decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (B) Left: The mean FPG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (C) Left: The mean 2 h PG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. Data presented as mean ± S.E. *p < 0.05. **p < 0.01.

Mentions: At week 12, the HbA1c levels of the Jinlida group and placebo group were 7.18 ± 1.13 and 7.8 ± 1.44, respectively, both lower than those from week 0. Compared to the changes in the HbA1c from week 0, Jinlida group level was reduced by 0.92 ± 1.09 and placebo group level was reduced by 0.53 ± 0.94. The 95% CI was 0.69–1.14 for the Jinlida group vs. 0.34–0.72 for the placebo group. At week 12, there was a very significant HbA1c reduction between the Jinlida group and placebo group (p < 0.01) (Fig 3A). The outcome data obtained from the seven study centers (sites) generally was uniformly distributed across the various sites.


The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.

Lian F, Tian J, Chen X, Li Z, Piao C, Guo J, Ma L, Zhao L, Xia C, Wang CZ, Yuan CS, Tong X - PLoS ONE (2015)

Changes in HbA1c, FPG and 2 h PG in the Jinlida group and placebo group.(A) Left: The mean HbAlc decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (B) Left: The mean FPG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (C) Left: The mean 2 h PG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. Data presented as mean ± S.E. *p < 0.05. **p < 0.01.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4476735&req=5

pone.0130550.g003: Changes in HbA1c, FPG and 2 h PG in the Jinlida group and placebo group.(A) Left: The mean HbAlc decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (B) Left: The mean FPG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. (C) Left: The mean 2 h PG decreased significantly in both groups between the baseline and after treatment. Right: There was a very significant statistical difference in the change between the two groups at week 12. Data presented as mean ± S.E. *p < 0.05. **p < 0.01.
Mentions: At week 12, the HbA1c levels of the Jinlida group and placebo group were 7.18 ± 1.13 and 7.8 ± 1.44, respectively, both lower than those from week 0. Compared to the changes in the HbA1c from week 0, Jinlida group level was reduced by 0.92 ± 1.09 and placebo group level was reduced by 0.53 ± 0.94. The 95% CI was 0.69–1.14 for the Jinlida group vs. 0.34–0.72 for the placebo group. At week 12, there was a very significant HbA1c reduction between the Jinlida group and placebo group (p < 0.01) (Fig 3A). The outcome data obtained from the seven study centers (sites) generally was uniformly distributed across the various sites.

Bottom Line: There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01).No serious adverse events were reported.Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone.

View Article: PubMed Central - PubMed

Affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

ABSTRACT

Background: Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone.

Methods: A total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2 h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA-β) were also evaluated.

Results: At week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69-1.14 for the Jinlida group vs. 0.34-0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2 h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported.

Conclusion: Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy.

Trial registration: Chinese Clinical Trial Register ChiCTR-TRC-13003159.

No MeSH data available.


Related in: MedlinePlus